A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma
Loma Linda University
Summary
The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.
Description
Primary Endpoint: R0 resection rate ≥ 70% Secondary Endpoints: Disease free survival, Overall survival, Perioperative mortality and morbidity Treatment should start within 28 days of registration. Pre-operative Chemotherapy Patients will receive a combination of the agents (gemcitabine and nab-paclitaxel) prior to surgery for a maximum of four cycles. Gemcitabine 1000 mg-m2 IV on days 1, 8, 15 Nab-paclitaxel 125 mg-m2 IV on days 1, 8, 15 28 day cycles Post-operative Chemotherapy Treatment should start within 5-10 weeks of surgery. Patients will receive a combination of the agents (gemcitab…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria (all criteria must apply): * Cytologic or histologic proof of adenocarcinoma of the pancreas. * Localized, potentially resectable tumors. * Greater or equal to 18 years of age. * ECOG performance status of 0 or 1. * Adequate hematologic, renal and hepatic function as defined by: * ANC greater or equal to 1,500 cells/mm3 * Platelets greater or equal to 100,000 cells/mm3 * Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) * Serum creatinine ≤ 2 x ULN • ALT ≤ 5 x ULN * AST ≤ 5 x ULN * No history of prior therapy for pancreatic cancer. * No history of active infection requiri…
Interventions
- DrugGemcitabine 1000 mg
Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)
- Drugnab-paclitaxel
Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)
- RadiationStereotactic Body Radiation Therapy
Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.
Location
- Loma Linda University HealthLoma Linda, California